Select Committee on European Communities Minutes of Evidence

Examination of witnesses (Questions 435 - 459)




  435.  Thank you for coming to give evidence and assisting in our enquiry into genetic modification. Both of your departments some months ago provided useful background information in writing and orally on this subject. First, perhaps you would describe briefly your areas of responsibility.
  (Dr Bell)  I am Jon Bell, head of the Novel Foods Division in MAFF. My division is responsible for developing and implementing policy on genetically-modified foods and also has a co-ordination role in MAFF for biotechnology issues generally. On my left is Mr Nick Tomlinson who heads the branch within my division that deals with these issues. On my far right is Dr Linda Smith, Head of the Biotechnology Unit at DETR, who deals with the issue of the deliberate release of GMOs. On my immediate right is Dr Parish, one of the senior scientists working in Dr Smith's unit.

Lord Gallacher

  436.  Dr Bell, to what parts of the Commission's proposed revision of 90/220/EEC are you opposed and why?
  (Dr Bell)  Perhaps Dr Smith from the DETR can lead on this matter.
  (Dr Smith)  DETR officials are carrying out substantive negotiations on the directive. The United Kingdom has welcomed the proposal from the European Commission to amend the directive on deliberate release. The aim is to secure that the directive retains fully the requirement to protect human health and the environment and at the same time makes provision to allow the technology to develop and take due account of relevant experience. Many of the proposed changes broadly fulfil this aim. Although the details are still to be worked out in some areas and some amendments are needed to secure harmonised implementation across the Community, broadly we are happy with the thrust of the directive.

However, there are some concerns. One of them is the proposal to remove from the scope of the directive products under development which would be covered by Community legislation to provide for specific environmental risk assessment similar to that in the directive. The Government are concerned that this could have the result of environmental effects not being taken adequately into account at the research stage because of the need to weigh them against other considerations addressed under product legislation. This would take the oversight of research releases away from the competent authorities for the purposes of this directive. These competent authorities have the relevant expertise and ability to evaluate these environmental risk assessments. This would not encourage public confidence in the regulatory regime and, further, the proposal would not be helpful for those wishing to conduct research releases because one research release might require several approvals if this particular procedure was adopted. This could result in far more bureaucracy and longer time than the current maximum of 90 days before research approval was granted.

Another concern is the loss in the proposal of the possibility for Member States' competent authorities to request simplified procedures. Under the existing directive only one simplified procedure has been adopted, but this has proved very important. While it does not reduce the information and risk assessment requirements it allows a single application to cover an entire plant breeding programme. The Government consider that the simplified procedure should be retained along with the facility to introduce other simplified procedures in order that the procedures can be adjusted if appropriate to reflect growing experience.


  437.  Are those the only criticisms at the moment?
  (Dr Smith)  There are further points. Do you wish me to stop here or go on?

  438.  I think, perhaps, I would rather like you to continue.
  (Dr Smith)  There are two further concerns. The Commission proposes to introduce two categories of research releases. At first sight this may be thought to be equivalent to the United Kingdom's fast track procedure for approvals for research releases by which for certain releases our own advisory committee on releases to the environment has identified certain things as low risk. We are able to make decisions on applications within 30 days, although without any reduction in the information and risk assessment requirements. That has worked satisfactorily in the United Kingdom. However, the approach proposed by the Commission for the two categories is different and may be difficult to implement because the categories are only broadly defined at present. As a consequence, we are concerned that this may result in uneven implementation across the Community. In addition, the procedures for the categories for which there is considered to be sufficient experience do not lighten the burden in terms of information requirements but only reduce the time within which the authorities have to make a decision. Therefore, this does not fully reflect the risk-based approach and in future when the number of applications increases could perhaps compromise the ability of the competent authorities to give due consideration to less familiar releases.

The other concern is that the Commission recently decided to seek the advice of the relevant Community level scientific committee on all notifications to market GMOs and the proposal for amendment of the directive would hamper this procedure. The Government wish to ensure that any decisions made on the renewal or otherwise of consents are based on sound science and referral of certain notifications to a scientific committee may help to secure this. However, the current proposal does not set out any period within which the committee would have to assess each application; nor does it set out the role of the committee in the approval process. We want that to be clarified.

  439.  Do you think that this may result in the whole process taking longer in future than it does currently?
  (Dr Smith)  That is one of the concerns. Although the new proposal and directive sets a clear timetable for all the other steps in the procedure there is no timetable set for that which could introduce lengthy delays.

  440.  What about the attempt to introduce agreed principles for risk assessment? Do you think that would be effective? Are you in favour of that?
  (Dr Smith)  We are very definitely in favour of that. One of the problems with the existing directive is that Member States have adopted different views on the risk assessment procedure. Although there has been a competent authority working party looking at that matter, it would be much clearer if it was set out in the directive so that Member States could work in harmony.

  441.  Are you happy with the introduction of an ethics committee?
  (Dr Smith)  In the recitals to the directive there is a proposal for an ethics committee to look broadly at biotechnology issues. We believe that that is a good idea.

  442.  Referring to the scientific committees at Community level, are you happy with the method by which their membership is determined?
  (Dr Smith)  We have some concerns there. It is not completely transparent how the members of those committees are selected. We have been trying to find out more information about that.

  443.  Are you happy with the seven-year limitation on consents for commercial releases?
  (Dr Smith)  We have some concerns about that for two reasons. We do not have a problem with the idea of having a time limit on the consent provided there is a well set out procedure for reviewing the consent if things are satisfactory and provided the consent continues in force until that has been resolved. There is also a concern as to whether seven years is the appropriate length of time. We would like to discuss that during negotiations on the directive.

  444.  Do you believe that such a period should be longer or shorter?
  (Dr Smith)  We have had representations both ways. Plant breeders who have obtained marketing consent for a particular genetically-modified crop need to breed that trait into different varieties and perhaps seven years will not give them long enough in order to bring those different varieties to market and make use of them.

  445.  There are provisions for monitoring in the revised directive, but it does not say much about the nature of the monitoring. Do you think that that should be more specific?
  (Dr Smith)  Yes. The Government are committed to ensuring appropriate monitoring for the introduction of genetically-modified organisms into commercial agriculture. The existing situation is that consents for experimental releases for marketing are given on the basis of a risk assessment which has to demonstrate that any risks to human health or the environment have been avoided or minimised. The purpose of monitoring consents, particularly after they have been granted, is to verify that the assumptions in the risk assessment are correct. We feel that for the post-marketing consents it should be specifically identified on a case-by-case basis what the monitoring should be. It should be based on the risk assessment for which the consent is granted.

Lord Wade of Chorlton

  446.  Are you aware of the response to these proposals by other Member States?
  (Dr Smith)  The negotiations on the directive started in the Council working group last week. There is a working group meeting this morning at which countries will be stating their position. Generally, there is very favourable opinion among other Member States for the amendments to the directive, although most countries have reservations about certain aspects and wish some of the proposals to be clarified before they can agree with them.

Lord Willoughby de Broke

  447.  You said that you were in favour of retaining the simplified procedures for research releases but that they may be excluded under the new proposals. What sort of support have you had for the simplified procedures route among fellow members of the European Union?
  (Dr Smith)  The current simplified procedure was an amalgamated proposal by several countries. France, Germany, the United Kingdom and the Netherlands had proposed simplified procedures. The one adopted was an amalgam of those proposals. We have support among other Member States for that.

Lord Wade of Chorlton

  448.  It has been put to us that risk assessment using evidence gleaned from tiny trial releases designed for safety is a farcical process. Do you agree with that? Is there a better way of dealing with risk assessment?
  (Dr Parish)  In the Government's view there are no valid alternatives to research trials carried out in the field to generate the necessary data for either scaling up research trials in the environment or making applications to place a product on the market. It is important to start with the laboratory studies to obtain basic information, for example to detemine whether the product may be toxic or allergenic. But that data only helps to establish whether or not the product is hazardous. It is very important to validate those laboratory studies in a real field situation and find out whether those hazards are likely to be realised and what the magnitude of the consequences may be. Therefore, that establishes the particular risk in the field. The current deliberate release directive sets out some important principles in the 10th, 11th and 12th recitals with respect to the carrying out of field trials to generate valid data to place products on the market. They also set out the step-by-step principle whereby one starts releasing genetically-modified organisms in very small trials with risk management in place. For example, for oilseed rape one may consider using isolation distances or pollen barriers. As one generates more data from those field trials one makes an application to scale up the size of the release. We are very much in favour of the step-by-step principle in order to generate data to satisfy ourselves that it is safe to scale up and once data is available from larger releases we have data to support an application to place the product on the market.

  449.  In your view how do the present risk assessments take into account the potential secondary effects of GM products?
  (Dr Parish)  It depends on how one chooses to define the term "secondary effects". The first interpretation is whether the genetically-modified organism has a direct effect. For example, an insect-resistant crop may affect the target pest. If we mean "secondary effect" to mean the effect on those organisms that may eat or parasitise those pests then those secondary effects are currently considered in our risk assessment. If we mean "secondary effects" as meaning effects that are not exerted by the GMO itself but as a result of managing the GMO, for example changes in herbicide use or other measures that may be necessary to grow the product in an agricultural situation, those effects are not formally addressed in our current risk assessment under the GMO regulations. However, it is important to bear in mind that the use of herbicides on such crops would be governed under other relevant legislation, for example the pesticides regulations, which also scrutinises safety to the environment and human health before making a decision on whether or not to give approval. We are currently taking steps to address the wider issues in respect of management to review our current legislation and identify whether or not there are any gaps.

  450.  When you talk about the assessment of risk are you looking for a nil risk or levels of risk which you regard as acceptable? When does a risk become acceptable?
  (Dr Parish)  That is a very searching question. First, it would be very unscientific. ACRE would not be able to come to a judgment on the concept of zero risk. There is no such thing as zero risk. One must accept that the growing of crops in agricultural situations will have some side effects on wild life, just as the result of cultivating a crop and controlling necessarily weeds and pests. Therefore, one must look at risk in terms of ensuring that it is minimised and address it on a case-by-case basis for each application that is looked at.

Lord Jopling

  451.  There is considerable concern about the adequacy of the steps being taken in relation to risk assessment. The Sub-Committee has been provided with a paper by Prof Williamson of the University of York entitled Biological Invasions first published in 1996. This paper is concerned with modified corn. He points out: "In corn, male sterility is a most useful agronomic trait. . .Texas cytoplasm varieties are male sterile because of a change in a mitochondrial gene. . . Remarkably, the same molecular mechanism that made the plants male-sterile also made the plants susceptible to a fungal pathogen, Bipolaris maydis race T. About two decades after the gene, T-urf13, came into commercial use the fungal disease devastated the corn containing that gene, which was by that time 85 per cent of the US corn hectareage, and made the innovation useless. The molecular details were known, the pathogen was known, but the interaction was not predicted and the consequences did not appear until the new genotype was in full commercial use." That is two decades later. It seems to me that in a situation of this sort in another case the problem may not be a fungal infection of that species but perhaps a secondary effect on human beings who eat that product. Are you not concerned by evidence of this sort? How can you carry out proper risk assessment that can cover an eventuality of that kind? That is what causes many of us on this Sub-Committee anxiety.
  (Dr Smith)  In assessing any proposal whether or not to release a genetically-modified organism the regulations require a large body of evidence to be provided. We offer a step-by-step approval procedure such that these trials are started in a small way and further information is gathered before the product is approved for marketing. Before the product is approved for marketing it is scrutinised by the competent authorities in all the Member States. They will make their decision based on the evidence before them, but there is always a possibility that unpredicted effects may arise. That is one of the reasons why monitoring of the product once it has been approved is so important. That is why we welcome the initiative of the Commission to take that into account. One of the conditions of any consent that is granted is that the holders of the consent must keep up to date with developments and inform the competent authorities as soon as new information is available about the particular product such that the consent can be reassessed. If appropriate, consent can be withdrawn by the authorities. But uncertainty and unpredicted effects are such that we have to make the decision on the best available evidence. The monitoring and procedures in place for checking what happens when products are introduced on to the market are part of the consent procedure.
  (Dr Bell)  I very much endorse that general approach. At the moment, we are using the best advice that we can obtain in this country when considering these applications. That is supplemented and amplified by the best advice that other Member States can offer. This is not a decision that we take in isolation. It also builds on experience that has been obtained elsewhere, including in the United States where this technology is well advanced. But we cannot give a one hundred per cent guarantee that every eventuality has been covered. It is only possible to do that in the context of the knowledge of those who are involved in it. Clearly, it would be difficult to see how we could ever reach that position. We shall learn from experience, and experience in other areas indicates that products should be approved and allowed to go into the food supply, provided they are considered safe on the basis of current knowledge. Therefore, monitoring is a very important back-up and reassurance for picking up any longer-term effects. We are considering now how best that can be done.

  452.  To sum up what has just been said, is it right to say that we are embarking into a potentially dangerous unknown area?
  (Dr Bell)  I think that that is overstating the case. Clearly, if the Government and their advisers thought that they were taking inordinate risks in the way that these things were being put through the system they would not be approved until further evidence was available. This is a matter involving public health and the Government take it very seriously as you would expect. It will not agree to sign off a request for approval for something to go on the market here or in the European Union that may carry serious health risks. Every piece of scrutiny that can possibly be carried out is carried out. This draws on knowledge worldwide, not just in this country.

  453.  Dr Smith, is it a potentially dangerous unknown?
  (Dr Smith)  I endorse what Dr Bell has said. We have a good understanding of plants and their biology. The advice that we have received from our expert committee on risks to the environment based in this country is that it would not grant a consent unless it was satisfied that the risks had been minimised and it had sufficient information available to it before making that decision. If it feels that it does not have sufficient information on a matter where it has identified a potential risk it will ask the applicant to obtain that information before approval is granted.

Lord Moran

  454.  Lord Jopling quoted the American case. I understand that it is impossible to predict everything. But in that particular case after 20 years 85 per cent of the US crop was of the single variety that caused a disaster. Do you think that there should be some arrangement to make the introduction of new species, once consent has been agreed, more gradual, through monitoring, and prevent a wholesale catastrophe of that sort from happening?
  (Dr Smith)  I am not familiar with the paper that has been quoted. I am not sure if the observed effect was as a result of a genetically-modified crop or conventional breeding.

Lord Jopling

  455.  Professor Williamson claims it is genetically modified: Zea mays.
  (Mr Tomlinson)  Given the timescale referred to in the paper and the fact that it was being grown commercially 20 years ago, it is extremely unlikely that it is a genetically-modified variety in the sense referred to in directive 90/220. It may well be that a gene from another variety of maize had been incorporated through conventional plant breeding. That points to the fact that there is a need to ensure there is a constant turnover of plant varieties to minimise the build up of plant diseases.


  456.  This is a matter that can be taken up with Prof Williamson when he comes before the Sub-Committee next week.
  (Dr Smith)  As none of us is immediately familiar with the specific papers, perhaps we can submit a supplementary comment after this session.

  457.  I should like to return to one matter to which Dr Parish referred, namely the indirect environmental and other effects which are not currently taken care of by existing committees. Dr Parish said that the department was looking at the legislative implications of taking account of that. Can you say a little more about Government thinking in that area? We have had various recommendations put to us either for changing the existing remit of the environmental committee or introducing some other overarching committee. How can account be taken of such factors in the regulatory process?
  (Dr Parish)  The Government's thinking on addressing the indirect effects is still very much in its early stages. We have been discussing with English Nature and other bodies such as the Royal Society for the Protection of Birds concerns about biodiversity and the possible effect of GMOs on species if they were introduced on a wide commercial scale. Once we have finished our discussions with them we shall be putting proposals or options to Ministers later this summer. That will go out for wider consultation in the autumn. The options that have been raised, for example expanding the remit of ACRE or having another regulatory committee to look at overarching issues, will be considered and put to Ministers. We are still very much in the early stages.

  458.  You mentioned English Nature. You will be aware that that body has called for a moratorium for a number of years until further research has been carried out and we know more about the problems. This is not a wild and woolly bunch; it is the Government's own organisation that has responsibility for advice on nature conservation in England. Do you have a view on that?
  (Dr Smith)  English Nature has submitted a paper to this Sub-Committee. As statutory advisers to the Department of the Environment that statement is being taken most seriously. It is one of the inputs into the review of the way in which risks are assessed which the Government are undertaking at the moment.


  459.  Therefore, you do not rule out the possibility of a moratorium?
  (Dr Smith)  The evidence that has been submitted is being considered. I should make it clear that the call by English Nature for a moratorium is very specific. It refers to the possibility of one particular genetically-modified crop being introduced into commercial agriculture: GM oilseed rape. At the present it is still awaiting marketing approval by the French competent authorities and those responsible for putting the seed on the national list of seed varieties in the United Kingdom or the common catalogue in the European Union. At present this product does not have approval.

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